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Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

By deferring several important, previously proposed Food and Drug Administration (FDA) actions to a future report by the Institute of Medicine (IOM) – often because the device industry did not agree with these proposals when first issued by the FDA in August 2010 – the FDA is not being forceful enough about improving the safety and effectiveness of new devices.

In a “Letter to the American Public” written today by Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, Shuren discusses the need to encourage innovation but also to assure the safety and effectiveness of medical devices. The FDA’s announcement today at least temporarily yields to the so-called innovation side of that equation.

Ironically, in the 510(k) process, whereby medical devices can essentially avoid rigorous pre-market studies for safety and effectiveness as long as they can establish their “substantial equivalence” to an existing or predicate medical device, the degree of “innovation” is theoretically limited by companies’ need to demonstrate how similar the 510(k) device is to devices already available.

Class III medical devices are high-risk or novel devices, most of which require direct demonstration of safety and effectiveness through the premarket approval (PMA) pathway.

But class II devices generally present less risk to patients and, in most cases, manufacturers must merely submit 510(k) substantially equivalent applications before marketing. There is little dispute that the industry, with FDA being complicit, has widely abused this process in the past.

Because some class II devices can also have substantial risks – especially if they are implantable, life-supporting or life-sustaining – the FDA proposed in August 2010 to develop a guidance “to define … a subset of class II devices called ‘class IIb’ devices, for which clinical information, manufacturing information, or, potentially, additional evaluation in the post-market setting would typically be necessary to support a substantial equivalence determination.” The agency’s reasoning was that “potential candidates for this device subset may include implantable devices, life-sustaining devices and life-supporting devices, which present greater risks than other class II device types.”

In our comments to this proposal, filed with the FDA in October 2010, we stated that: “Because the 510(k) process, as it is presently implemented, has failed to consistently protect the public health, we strongly advocate the division of class II devices so as to further stratify risk and guide premarket scrutiny. The existing statute permits the FDA to require clinical data in 510(k) applications. The agency should therefore do so for all devices subclassified into class IIb: All devices that are implantable, life-sustaining or life-supporting.”

In today’s announcement, the FDA described significant industry opposition to this class IIb proposal, perhaps because it might actually have to test some devices that now need only show substantial equivalence. The document also stated, however, that “Foreign regulatory bodies were supportive of the creation of a Class IIb because it would bring U.S. regulations closer to those of the European Union.”

Other important issues that the FDA deferred to the future IOM study, often because of industry opposition, included the need to:

● Define the scope and grounds for rescinding a 510(k) device clearance (currently, such authority is lacking);
● Seek more authority to require post-marketing studies as a condition of approval; and
● Clarify when a device should no longer be available as a predicate for a subsequent 510(k) device application.

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